Efficacy and Safety of Beta-adrenoceptor Inverse Agonist, Nadolol, in Mild Asthma
Mild Persistent Asthma, Uncomplicated

About this trial
This is an interventional treatment trial for Mild Persistent Asthma, Uncomplicated
Eligibility Criteria
Inclusion Criteria:
Individuals who meet all of the following criteria are eligible for enrollment as study participants:
1. Males and females with physician-diagnosed asthma between the ages of 18- 60.
2. Pre-bronchodilator FEV1 80% or greater than the predicted value
3. Baseline PC20 (based on FEV1) ≤ 4 mg/ml on methacholine challenge test.
4. Asthma Control Questionnaire Score (ACQ) <1.25
5. Baseline blood pressure ≥ 110/65mm Hg
6. Baseline pulse rate ≥ 60 beats/min.
7. Never-smoker or former-smoker < 10 pack.year and has not smoked within 1 year.
8. Able to complete diary cards and comply with study procedures.
9. Females of childbearing age may participate only if they have a negative pregnancy test, are non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study.
Exclusion Criteria:
Subjects who meet ANY of the following criteria are not eligible for enrollment:
- Inability or unwillingness of the participant to give written informed consent
- History of upper/lower respiratory tract infection or asthma exacerbation requiring systemic steroids within 6 weeks of Visit 1
- Use of rescue medication (e.g., albuterol) more than twice per week during the week preceding Visit 1 excluding the use of such medication as preventative prior to exercise.
- History of hospitalization for asthma in the preceding year
- History of intubation for asthma
- Currently diagnosed with chronic obstructive pulmonary disease (COPD)
- Currently taking any beta-blocker medication
- History of adverse reaction or allergy to any beta-blocker medication
- History of neurological, hepatic, renal, or other medical conditions that may interfere with the interpretation of data or the patient's participation in the study or may increase safety concerns
- Current diabetes or hyperthyroidism
- History of cardiovascular diseases including uncontrolled hypertension (BP >160/100), ischemic heart disease, congestive heart failure, valvular heart disease or cardiomyopathy
- Known allergy or sensitivity to atropine or ipratropium bromide
- Abnormal entry laboratory values at baseline except for the following tests, where values outside the normal limits will be acceptable as follows: Hct ≥ 30%, platelet count > 100,000, ALT and AST < 1.5 x upper normal limit
- Known bleeding disorders, platelet count <100,000, PT or PTT > 1.5 x normal control (if participating in bronchoscopy sub-study)
- Known allergy to lidocaine (if participating in bronchoscopy sub-study)
- Documented or self-reported current history of alcoholism or drug abuse
- Participation in another research trial within 30 days of starting this trial
- Unwillingness or inability to comply with study procedures
- Inability to swallow the study medication capsule
- Use of any exclusion medication within the time period specified
- Pregnant or nursing
- Receiving allergen immunotherapy (desensitization injections)
Sites / Locations
- Washington University School of Medicine
- Duke University Medical Center
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Active, nadolol
Placebo
Active